Healthcare Professionals

Endurant II Stent Graft Systems

EVAR Procedures

Overview

Choose the AAA proven solution as varied as your patients. The Endurant™ II system family of products provides the standard of care with a legacy of clinical success for the treatment of abdominal aortic aneurysm (AAA). For the past 5 years, the Endurant II stent graft system has been used in 1 out of 2 EVAR cases.* Only the Endurant II stent graft has the deep clinical experience and favorable clinical outcomes designed to treat both straightforward and challenging anatomy.


INDICATIONS

The Endurant™ II/Endurant™ IIs bifurcated stent grafts are indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. They may be utilized in conjunction with the Heli-FX EndoAnchor System when augmented radial fixation and/or sealing is required; in particular, in the treatment of abdominal aortic aneurysms with short (≥ 4 mm and < 10 mm) infrarenal necks. The Endurant II Stent Graft System aorto-uni-iliac (AUI) stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in patients whose anatomy does not allow the use of a bifurcated stent graft. The Endurant II/IIs Stent Graft System is indicated for use in patients with the following characteristics:

  • Adequate iliac or femoral access that is compatible with vascular access techniques, devices, or accessories
  • Proximal neck length of
    • ≥ 10 mm; or
    • ≥ 4 mm and < 10 mm when used in conjunction with the Heli-FX EndoAnchor System (bifurcated stent graft only)

Note: Neck length is defined as the length over which the aortic diameter remains within 10% of the infrarenal diameter.

  • Infrarenal neck angulation of ≤ 60°
  • Aortic neck diameters with a range of 19 to 32 mm
  • Distal fixation length(s) of ≥ 15 mm
  • Iliac diameters with a range of 8 to 25 mm
  • Morphology suitable for aneurysm repair

Endurant II/IIs Stent Graft Product Features

Endurant II Family of Products

The Endurant II family:

  • Includes Endurant II, Endurant II AUI and Endurant IIs stent grafts
  • Designed to meet a wide range of patient anatomies
  • Utilizes the Endurant II delivery system, which allows for accurate placement and controlled deployment
Endurant Stent Products

Endurant IIs stent graft is a three-piece system that:

  • Leverages the proven design of the leading Endurant II abdominal stent graft
  • Expands anatomical customization options
  • Offers a shorter ipsilateral leg for more flexible, targeted limb placement
  • Features equal leg diameters to allow limbs to be used on either side
  • Utilizes the existing delivery system allowing accurate placement and controlled deployment

The Endurant IIs stent graft:

  • Provides up to a 20% reduction in distal diameter compared to select Endurant II bifurs
  • Enables in situ sizing with select ipsilateral limbs, allowing a 3-5 stent overlap for adjustment during case
  • Allows easier pre-case planning to simplify sizing

Endurant II Stent Graft Features

  1. Flexibility and conformability. Designed to conform to the natural tortuosity of the vessel. Low-profile, hydrophilic delivery coating enhances access and trackability.
  2. Accurate placement and controlled deployment. Flexible, kink-resistant delivery system facilitates stent graft delivery. Tip capture for precise positioning adjustments, including adjustment of placement proximally or distally.
  3. Optimal seal and fixation. M-shaped proximal stents provide wall apposition and minimize in-folding. Suprarenal stent anchor pins provide secure fixation.
  4. Durability and strength. High-density, multifilament polyester graft material provides lower porosity for resistance against aneurysm sac growth.
Endurant II Stent Graft Features

Delivery and Deployment

The Endurant II delivery system helps ensure precise control and accurate placement at every stage of deployment:

  • 100% PEVAR delivery and deployment success§
  • 99.3% delivery and deployment success

Tip capture delivery allows precise adjustment of position, proximally or distally, even after deployment of three stent rings. Control the release of the suprarenal stent and anchor pins with the back-end thumb wheel.

Endurant II Delivery System Controlled Deployment
Deployment, capture, and release of the Endurant II stent.

Endurant II Controlled Deployment

Deployment of the Endurant IIs Stent Graft

View an animation of the Endurant IIs stent graft deployment.
More information (see more)Less information (see less)

Deployment of the Endurant II Stent Graft

View an animation of the Endurant II stent deployment.
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Data on file at Medtronic.

† As of December 2017.

‡ Bench test data on file at Medtronic. Bench test data may not be indicative of clinical performance.

§ Data on file from the 178 de novo patients from the ENGAGE Post-Approval Study (PAS).

‖ Delivery success = successful vascular access and delivery of the device to the intended anatomical treatment site. Deployment success = successful deployment of the device in the intended site and the successful removal of the delivery system. Endurant™ US IDE trial: Makaroun M. One-year outcomes of the US regulatory trial of the Endurant™ stent graft system. J Vasc Surg. 2011; 54:601–608.


Manuals and Technical Guides

Instructions for Use
Find this technical manual in the Medtronic Manual Library, in the product labeling supplied with each device, or by calling 877-526-7890.


Model Specifications

ORDERING INFORMATION: ENDURANT II bifurcated devices

  Proximal
Graft
Diameter
(mm)
Distal
Graft
Diameter
(mm)
Distal
Design
Total
Covered
Length
(mm)
Delivery
System
Catheter
Outer
Diameter
(F)
ETBF  23 13 C 124 E 18
ETBF  23 13 C 145 E 18
ETBF  23 13 C 166 E 18
ETBF  23 16 C 124 E 18
ETBF  23 16 C 145 E 18
ETBF  23 16 C 166 E 18
ETBF  25 13 C 124 E 18
ETBF  25 13 C 145 E 18
ETBF  25 13 C 166 E 18
ETBF  25 16 C 124 E 18
ETBF  25 16 C 145 E 18
ETBF  25 16 C 166 E 18
ETBF  28 13 C 124 E 18
ETBF  28 13 C 145 E 18
ETBF  28 13 C 166 E 18
ETBF  28 16 C 124 E 18
ETBF  28 16 C 145 E 18
ETBF  28 16 C 166 E 18
ETBF  28 20 C 124 E 18
ETBF  28 20 C 145 E 18
ETBF  28 20 C 166 E 18
ETBF  32 16 C 124 E 20
ETBF  32 16 C 145 E 20
ETBF  32 16 C 166 E 20
ETBF  32 20 C 124 E 20
ETBF  32 20 C 145 E 20
ETBF  32 20 C 166 E 20
ETBF  36 16 C 145 E 20
ETBF  36 16 C 166 E 20
ETBF  36 20 C 145 E 20
ETBF  36 20 C 166 E 20

 

ORDERING INFORMATION: Endurant IIs bifurcated devices

  Proximal
Graft
Diameter
(mm)
Distal
Graft
Diameter
(mm)
Distal
Design
Total
Covered
Length
(mm)
Delivery
System
Catheter
Outer
Diameter
(F)
ESBF  23 14 C 103 E 18
ESBF 25 14 C 103 E 18
ESBF 28 14 C 103 E 18
ESBF 32 14 C 103 E 20
ESBF 36 14 C 103 E 20

 

ORDERING INFORMATION: LIMBS*

 

Distal

Graft
Diameter
(mm)

Distal
Graft
Diameter
(mm)
Distal
Design
Total
Covered
Length
(mm)
Delivery
System
Catheter
Outer
Diameter
(F)
Total
Contralateral
Covered
Length with
EII/EIIs
Bifurcated
Total
Ipsilateral
Covered
Length with
EIIs
Bifurcated
ETLW 16 10 C 82 E 14 136 155
ETLW 16 10 C 93 E 14 147 166
ETLW 16 10 C 124 E 14 178 177-197
ETLW 16 10 C 156 E 16 210 209-229
ETLW 16 10 C 199 E 16 253 252-272
ETLW 16 13 C 82 E 14 136 155
ETLW 16 13 C 93 E 14 147 166
ETLW 16 13 C 124 E 14 178 177-197
ETLW 16 13 C 156 E 16 210 209-229
ETLW 16 13 C 199 E 16 253 252-272
ETLW 16 16 C 82 E 14 136 135-155
ETLW 16 16 C 93 E 14 147 146-166
ETLW 16 16 C 124 E 14 178 177-197
ETLW 16 16 C 156 E 16 210 209-229
ETLW 16 16 C 199 E 16 253 252-272
ETLW 16 20 C 82 E 16 136 155
ETLW 16 20 C 93 E 16 147 166
ETLW 16 20 C 124 E 16 178 177-197
ETLW 16 20 C 156 E 16 210 209-229
ETLW 16 20 C 199 E 16 253 252-272
ETLW 16 24 C 82 E 16 136 155
ETLW 16 24 C 93 E 16 147 166
ETLW 16 24 C 124 E 16 178 177-197
ETLW 16 24 C 156 E 16 210 209-229
ETLW 16 24 C 199 E 16 253 252-272
ETLW 16 28 C 82 E 16 136 155
ETLW 16 28 C 93 E 16 147 166
ETLW 16 28 C 124 E 16 178 177-197
ETLW 16 28 C 156 E 16 210 209-229
ETLW 16 28 C 199 E 16 253 252-272

 

* The limb mates with the AUI stent graft on the ipsilateral side.

These calculations assume the minimum 30 mm overlap between the bifurcated stent graft and the contralateral iliac limb per the Endurant II Stent Graft System Instructions For Use. When using the 124 mm length bifurcated stent graft, subtract 10 mm from Total Contralateral Covered Length with Bifurcated.

The 3-5 stent overlap is available only with select limbs. Please refer to the Instructions For Use for more information.

ORDERING INFORMATION: AORTIC EXTENSIONS

 

Proximal

Graft 
Diameter 
(mm)

Distal 
Graft 
Diameter 
(mm)
Distal 
Design
Total 
Covered 
Length 
(mm)
Delivery 
System
Catheter 
Outer 
Diameter 
(F)
ETCF  23 23 C 49 E 18
ETCF  25 25 C 49 E 18
ETCF  28 28 C 49 E 18
ETCF  32 32 C 49 E 20
ETCF  36 36 C 49 E 20
ETTF 23 23 C 70 E 18
ETTF 25 25 C 70 E 18
ETTF 28 28 C 70 E 18
ETTF 32 32 C 70 E 20
ETTF 36 36 C 70 E 20

 

ORDERING INFORMATION: ENDURANT II AUI

  Proximal
Graft
Diameter
(mm)
Distal
Graft
Diameter
(mm)
Distal
Design
Total
Covered
Length
(mm)
Delivery
System
Catheter
Outer
Diameter
(F)
ETUF 23 14 C 102 E 18
ETUF 25 14 C 102 E 18
ETUF 28 14 C 102 E 18
ETUF 32 14 C 102 E 20
ETUF 36 14 C 102 E 20

 

ORDERING INFORMATION: ILIAC EXTENSIONS

  Proximal
Graft
Diameter
(mm)
Distal
Graft
Diameter
(mm)
Distal
Design
Total
Covered
Length
(mm)
Delivery
System
Catheter
Outer
Diameter
(F)
ETEW  10 10 C 82 E 14
ETEW  13 13 C 82 E 14
ETEW  20 20 C 82 E 16
ETEW  24 24 C 82 E 16
ETEW  28 28 C 82 E 18